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Remarks as Delivered for Margaret A. Hamburg M.D.
Commissioner of Food and Drugs
at the
2010 BIO International Convention
May 5, 2010

Good morning and thank you, Jim, for that kind introduction. It’s a pleasure to be here today.

The issues that we are discussing this morning are of huge importance to all of us and our nation. I have been working on biosecurity and public health preparedness for many years now…and in fact with all of the people on this panel at different times in different roles.

This morning, I would like to speak to you about the important role that the Food and Drug Administration, plays in biosecurity and public health emergency preparedness…and outline some of the steps we are taking to help facilitate the development of medical countermeasures and ensure the safety of our food supply.

As a science-based regulatory agency charged with protecting the public health, the FDA sits in a unique position…and, as a result, we represent a very special piece of the preparedness puzzle.

FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of food, drugs, biological products, medical devices, cosmetics, some radiation-emitting products, and now, even tobacco products.

Which means that our responsibility and reach are enormous. In fact, the FDA regulates products that over 20 percent of every consumer dollar spent in this country.

I must admit that when I took this position, I didn’t fully appreciate the scope of the FDA’s task or how crucial the agency truly is. But what has become clear to me is that if we don’t do our job, there is no one to backstop behind us. And because our role is unique, it’s critical that we do it completely and responsibly.

When it comes to biosecurity, our goal must be to prepare for, protect from and respond to the devastating potential consequences of emerging infectious disease threats and bioterrorism. This means that we must have in place systems to prevent contamination or adulteration of important commodities such as food and medical products, from both natural causes and a deliberate efforts to do harm.

In addition, we must be able to help support a nimble, effective public health response to an unfolding biological event, including the need for the U.S. government to be able to assure an arsenal of safe and effective tools and medical countermeasures that can identify emerging threats, contain disease and protect the health and stability of the American people.

With respect to medical countermeasures, FDA, though not always the most visible component of our nation’s biosecurity and preparedness efforts, is certainly a fundamental partner in the medical countermeasure enterprise. Let me give you one quick example of the concrete and essential role that FDA can and must play.

Last year, the emergence of the novel H1N1 influenza virus posed a very real threat to the health of millions of Americans. Scientists—at FDA and many other agencies—worked around the clock to deliver diagnostics, medications and vaccines to the people who needed them most.

And we were largely successful.

A key step was the agency’s approval of multiple safe and effective vaccines against the novel H1N1 strain. Manufacturers produced the vaccine in FDA-licensed facilities and used the same steps they use every year to develop seasonal flu vaccines—a tried and true method that while not as scientifically sophisticated and efficient as we ultimately need, it does have a strong safety record on which to rely.

Vaccine lots were assessed by FDA inspectors for safety, purity and potency, and FDA collaborated with CDC and other agencies to watch for unexpected or severe adverse events. And though the vaccine became available more slowly than initially hoped, tens of millions of Americans were ultimately protected by a vaccine that has proved to have, as expected, an excellent safety profile.

But the vaccine wasn’t all that was needed. At the onset of the pandemic, there were no cleared diagnostic tests that could detect this H1N1 virus. This obviously presented a major gap in our ability to identify and monitor the virus, and to fully manage the epidemic.

Through the issuance of Emergency Use Authorizations we were able to authorize the use of novel diagnostics for H1N1. Treatment was also key. Using this same Emergency Use Authorization mechanism, we were able to permit the use of essential antiviral drugs in some important new ways…including expanded use of Tamilflu in age groups outside the originally approved indications, amended dosage formulations of Tamiflu for the very youngest patients, as well as the investigational intravenous antiviral drug, Peramivir, for critically ill patients.

We were also able to extend the shelf-life indications for antivirals in our National Stockpile and elsewhere such that vitally needed and still effective drugs could be used without unnecessary wastage and/or liability concerns. All of these decisions were, of course, made after careful review of the available data to support the safe and effective use of these interventions under these special emergency conditions

Clearly FDA’s role in evaluating safety and efficacy, and in making products available, directly impacts development on the front end and distribution on the back end. But there are constraints on our ability to do our job as effectively and efficiently as possible. Frankly, we need additional resources and support…Yes, more dollars, but we also need more human resources to address an expanding and increasingly complex portfolio of products for review. And, at least as importantly, we must strengthen our science.

I think everyone agrees that we must enhance our capacity and expertise to support the processes for reviewing medical products routinely, of course, but especially for high priority products so that they can be available in an emergency.

In order to successfully enhance this regulatory review, we must also make an urgent push to strengthen the regulatory science that underlies it. Modernizing the scientific knowledge base and capabilities is critical to help inform the medical countermeasure regulatory review process and effectively translate cutting-edge science and technology into the products needed to protect the American people.

We are mounting a new initiative to bolster regulatory science, which I believe will prove particularly valuable. We must harness advances in science and technology to streamline the regulatory pathway to develop and implement science-based tools, methods, models, standards, guidance, and pathways needed to evaluate product safety, efficacy and quality as swiftly and surely as possible

We plan to do this in three ways.

First, we are optimizing the medical product review process in order to speed development. We will engage with researchers earlier in the process and provide clear guidance on development and evaluation pathways. By identifying and resolving problems earlier on, and communicating more closely throughout the process, we will be able to speed progress toward approval, licensure or clearance, depending on the product.

Second, we plan to work with HHS to do a thorough assessment of the legal, regulatory and policy framework for medical countermeasures and fine-tune it where needed to ensure that it properly supports preparedness and response.

And finally, we are working to advance regulatory science capacity to improve countermeasure development and evaluation pathways…something that the government and other stakeholders have identified as a key area for action and investment.

Because it is so important, and because this is a BIO meeting, I want to talk little more concretely about the issue of strengthening the overall scientific capacity within FDA. When I became Commissioner about a year ago, a number of reports and advisory boards had warned about the dire state of science funding at FDA and how the scientific and regulatory demands were outstripping FDA’s capacity to respond.

The agency charged with judging the safety and efficacy of drugs and medical products—and monitoring the safety of those products once they are on the market—must possess a scientific capability equal to that task…and nowhere is this need more evident than in the area of biosecurity. After all, the American public relies on the FDA’s expert judgment during such public health emergencies. There’s no use in developing and stockpiling products if people don’t have the confidence to take them.

A strong scientific capacity will help us better deal with the new medical products coming before us…and will help us develop a comprehensive body of research to support regulatory review.

All of this is absolutely essential to the ability of FDA to do its job—and I am happy to report that we are making progress, with new attention and resources focused on strengthening the scientific capabilities needed.

In a preclinical setting, this means modernizing safety testing and developing better markers and models to predict product safety and efficacy. It means thinking hard about new models to assess the risk or benefit of medical products intended to treat the American people.

In a clinical setting, this means developing and using biomarkers and surrogate endpoints…developing and using flexible clinical trial designs and new clinical trial analytics to improve or speed evaluation and to reduce the number of patients required to achieve meaningful answers. It means validating new diagnostic tests to inform deployment and utilization of medical countermeasures as well as outbreak management and containment…and improving infrastructure and information science to evaluate products rapidly, especially in emergencies.

And in a manufacturing setting, this means facilitating rapid scale-up of production, improving quality and stability of products and developing better rapid methods to assess product purity, potency, quality and contamination. To address the range of serious potential threats before us, we must think and act in new ways.

Across all of these issues and settings, we are focused—above all else—on creating policies that meet the public health need. We play a fundamental role in ensuring that we have safe and effective tools for diagnosis, treatment and care. And we stand ready to fulfill that role.

Now let me shift gears and talk briefly about our role in ensuring the safety of our nation’s food supply. Food safety—which has been a cornerstone of public health activities and of FDA from our very beginning—usually refers to unintentional contamination and the control of food borne outbreaks.

But we also see cases of economically motivated adulteration, truly disturbing acts in which lives are put at risk for the sole purpose of turning a profit. Several years ago, for example, you may remember the melamine-contaminated protein ingredients manufactured in China, which made their way into certain dairy products as well as pet foods and animal feed—causing serious illness and even death.

In our modern world, we must also now focus on the possibility of deliberate contamination to cause physical harm to the American people and to elicit panic, social dislocations and economic damage. FDA has devoted significant efforts over the past nine years to preventing the intentional contamination of our food supply.

We’ve developed guidance documents for industry that suggest voluntary activities they can implement within their operations.

We’ve launched two food defense awareness campaigns for industry employees and managers that were very well received by industry.

We’ve partnered with the FBI, Department of Homeland Security, USDA, State and local government, and industry to conduct 17 different vulnerability assessments for FDA-regulated food commodities.

And we’ve developed an extensive international food defense outreach campaign to raise awareness and increase capacity to fight the threat of contamination. The campaign—which also reflects our expanding international programs—spans the globe from the Caribbean Basin to Central and South America to Southeast Asia to Northern Africa.

Especially in our increasingly globalized world, our food system is an extensive, open and complex structure that must receive the best possible protection against attack and adulteration. The public health demands it. But there remain key vulnerabilities that must be shored up.

As we sit here today, a critical piece of food safety legislation is awaiting passage by the Senate. This bill recognizes the vital importance of food safety to the health and security of our nation and the importance of putting in place a system of preventative controls, rather than scrambling to manage and contain disease after an outbreak emerges and takes hold.

Importantly, this legislation recognizes that FDA needs new authorities and resources if we are to do our important job, especially addressing the addition security concerns of the 21st century. I hope it will pass soon.

There is so much more to be done. I think it is time to conclude, but I look forward to working with everyone here—and to continuing the discussions that will make way for real progress on some of the most pressing challenges we face today.